NO - Artemis Medical
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1. c Is the provision of service repair information conditional upon completion of training YES NO 4 d In order to undertake maintenance repair calibration is any special software test equipment tooling required YES J NO If YES please indicate that details of special software test equipment tooling are provided on a separate sheet YES Y Ti a Is the supplier able to provide an as required repair maintenance service in the UK YES J NO b Is the supplier able to provide a contract repair maintenance service YES Y NO If YES please confirm that details of repair maintenance contracts are provided on a separate sheet YES J c i If repairs are normally performed by the supplier on the purchaser s site please state typical response time N A return to base ii If repairs are performed off site where will these be carried out Company Artemis Medical Ltd Location Dartford Typical turnround time 7 10 days iii Is free of charge loan equipment normally available YES NO J 8 Please state if repair parts will be available to the purchaser s or a third party s suitably trained and equipped personnel YES J NO If YES is the supply of repair parts conditional upon acquisition of repair information2. luer fitting for a Calibration Check and a male luer plug to be used for the Pneumatic Check Obtain a mercury electronic manometer whose accuracy meets the AAMI ANSI Standard for Non Automated Sphygmomanometers 1994 Temperature Calibration Key SpO Simulator Masimo Tester Pn 1593 Fixed volume 500 ml Pressure Cylinder CAS p n 01 02 0248 Page 4 of 5 Service Contract Prices January 2005 CAS 740 Patient Monitor Minimum 2 year contract term 1 annual 2 annual Call out insurance Spare parts visit visit Single payment covers 2 Insurance years Single payment covers 2 years CAS 740 1 NIBP 42 00 42 32 00 34 00 CAS 740 2 NIBP SpO 42 00 42 32 00 45 25 CAS 740 3 42 00 42 32 00 62 90 NIBP SpO Temp On Site Attendance Fee 147 00 per site visit only not per unit Notes 1 All accessories supplied during annual service visits will be charged for in addition e g Cuffs and hoses etc 2 Internal battery to be changed on 2 annual visit at an additional charge Non contract charges Call out 180 includes fault assessment and addressing any finger problems e g monitor not plugged in faulty sensor etc Hourly charge 100 per hour first hour 110 per hour thereafter charged in 30 minute increments All prices exclude VAT Page 5 of 5
3. the product comply Standard Test House Certificate Number Date SERVICE SPARES INSTALLATION 5 Is service repair information available YES J NO If NOT f o c please state current price 50 00 Indicate contents below Please state Full circuit diagrams NO Fault finding procedure YES Preventative maintenance YES YES NO or N A Repair information YES Spare parts listing YES List of special tools test equipment etc YES If YES please state whether also available on Disk YES Website NO If Web please state address 6 a In addition to the service repair information manual will training be required before technical personnel can provide First line maintenance Calibration YES Please state YES NO or N A b Is the supplier able to provide this training for the purchaser s or a third party s technical personnel YES NO If YES will this be free of charge Or chargeable 4 If NO please indicate if details of an organisation that is able to provide this training are available on request YES NO Page 1 of 5 Supplier s Reference PPQ CAS 740
4. Directive 90 385 EEC YES ii Medical Devices Directive 93 42 EEC YES J If YES state classification of device 93 42 EEC Annex IX Ilb iii Zn Vitro Diagnostic Medical Devices Directive 98 79 EC YES If YES is the device For self testing YES Covered by Annex II List A YES List B YES NO For ii and iii above Identification No of Notified Body if applicable 0086 iv EMC Directive 89 336 EEC or superseding directive YES v Low Voltage Directive 73 23 EEC YES vi Other Directive s please specify 2 a Is the product a custom made device 93 42 EEC YES NO 4 b Is the product intended for clinical investigation 93 42 EEC or performance evaluation 98 79 EC YES NO 4 If YES to a or b above does the device comply with the UK Medical Devices Regulations YES NO MANAGEMENT SYSTEM STANDARDS 3 a Is the manufacturer currently registered to any management system standards eg ISO 9001 ISO 14001 ISO 13485 YES 4 NO If YES please state the standard s and certification body EN46001 1996 ISO 13485 1996 ISO 9001 1994 b Is the supplier s service and repair organisation currently registered to any management system standards YES J NO If YES please state the standard s and certification body ISO 9001 2000 SAFETY STANDARDS 4 For products not CE marked to 1 b i ii or iii above with which safety standard s does
5. PRE PURCHASE QUESTIONNAIRE EXTENDED FORM PPQ June 2003 Produced by NHS Purchasing and Supply Agency Scottish Healthcare Supplies Northern Ireland CSA Regional Supplies Service and Welsh Health Supplies in conjunction with the Association of British Healthcare Industries This form is intended to supply prospective purchasers with information about equipment being considered for purchase It is intended principally for pre purchase information on electrical medical dental ophthalmic and laboratory equipment The form may also be used for other products including non electrical items and to give information prior to equipment being supplied on loan in which case not all the questions will be relevant Please ensure all relevant questions are answered For issue and completion by purchaser PPQ Master Reference 2087632 A unique reference preferably ten characters maximum must be given by the supplier Supplier s Reference PPQ CAS 740 Generic Device Type Vital signs Patient Monitor Equipment Model CAS 740 NIBP NIBP SpO2 NIBP SpO2 Temp Monitor Country of Origin USA Manufacturer CAS Supplier Artemis Medical Ltd Telephone No 01322 628877 Fax No 01322 628878 e mail info artemismedical co uk CE MARKING 1 a Does the product carry the CE marking YES J NO b If YES to which EC Directive s i Active Implantable Medical Devices
6. YES Jv Or training YES NO 9 Please indicate when this model was first placed on the market 2003 10 a Forhow many years from the date of last manufacture is the supply of spare parts guaranteed 7 years b Is the product still in current production YES NO If NO indicate year of last manufacture 11 Is installation necessary YES NO Jv If YES please confirm that details of all services required are provided on a separate sheet YES 12 Will software upgrades be notified N A YES Jv NO IONISING RADIATION 13 Does the product contain a source of ionising radiation or is it capable of emitting ionising radiation YES NO Jv DECONTAMINATION REPROCESSING 14 a i Will the item be reprocessed cleaned disinfected sterilised YES NO 4 If NO go to Question 15 ii If YES is the item intended to be Non sterile for single use Sterilized Disinfected Y Other See Append 1 iii Is there a recommended maximum number of uses YES NO A If YES please state iv Are decontamination reprocessing instructions supplied YES J NO v Are instructions available for safe disposal YES NO b i Is manual cleaning the only cleaning method specified before further reprocessing YES Y NO ii What is the maximum temperature that can be used for thermal disinfection Temp NA iii Are there any restrictions on detergent disinfectant types YES NO If YES please state iv Can the item withstand autoclaving at 137 C for 3 mins YES NO Jv v Is the item compat
7. ible with other sterilization methods YES NO If YES please state NA vi Does reprocessing require the use of specified equipment YES NO Jv If YES please state equipment type eg containers processors etc and where appropriate parameters of operation eg temp pressure etc NA c i Are tools required to aid dismantling reassembly or are lubricants required YES NO 4 ii If YES are they supplied with the device or available optionally Supplied Optional Neither d Is decontamination reprocessing training available YES NO ow If YES will this be Free of charge Chargeable e Are reprocessing instructions available on the Web YES NO y If YES please state address WARRANTY 15 Please confirm that a copy of the warranty is provided on a separate sheet YES J DECLARATION When reference is made to this form and its attachments within the process of obtaining the item we agree that the purchaser will be entitled to rely upon the contents and subsequent non compliance with the statements contained herein will entitle the purchaser to seek redress Name David Stow Position Managing Director Company Address Artemis Medical Ltd Butterly Avenue Questor Business Park Dartford Kent DA1 1JG Date 14 December 2005 Page 2 of 5 Append 1 CLEANING DECONTAMINATION CLEANING OVERVIEW CAUTION Do not open the monitor to clean or repair it Contact CAS Medical System for service needs WARNING Do not under any circ
8. nd disposable or single patient use products for out of box failure only Where the accessory is not a CAS manufactured product the manufacturers own warranty conditions apply CAS reserves the right to perform warranty service operations in its own factory at an authorized repair facility or at the customers site Our obligation under this warranty is limited to repairing or at our option replacing any defective parts or our equipment without charge if such defects occur in normal service and with prompt notification Damage to any part through misuse neglect or accident or by affixing any accessories or attachments other than CAS Masimoe Nellcore Nonine and Welch Allyne manufactured accessories or attachments is not covered by this warranty ACCESSORIES BATTERIES CUFFS AND CERTAIN COMPONENTS In all cases policy applies from date of purchase from CAS or its authorized distributors or agents Accessories Ninety 90 Days Masimo Nellcor and Nonin Sensors Welch Allyn Temperature Probes Batteries One 1 Year Cuffs all Out of box failure only External Printer One 1 Year Other Accessories Out of box failure only THERE ARE NO WARRANTIES WHICH EXTEND BEYOND THOSE EXPRESSLY DESCRIBED IN THIS AGREEMENT AND THE COMPANY MAKES NO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE Service Tools A Calibration Kit is included with the monitor The kit contains a T connector with a male and a female
9. p soak a cloth with mild detergent wring well and wipe Dry by wiping with a soft dry cloth CAUTION Before cleaning the printer disconnect the AC adapter from the printer Do not use volatile chemicals such as thinner benzine etc Never wet the inside of the printer mechanism Refer to the printer User s Manual for more information Page 3 of 5 WARRANTY POLICY MONITORS CAS 740 Warranty excludes accidental and malicious damage Warranty void if main unit has been opened without prior written authorisation by Artemis Medical Authorisation will generally only be granted when suitably qualified Trust bio med personnel have received technical training by Artemis Medical or CAS Minimum qualification for technical training is HNC ONC or equivalent in Medical Electronics or similar CAS Medical Systems Inc warrants the monitor when new to be free from defects in material and workmanship and to perform in accordance with manufacturer s specifications for a period of two 2 years from the date of original purchase from CAS or its authorized distributors or agents except as noted below The same warranty conditions are made for a period of one 1 year with respect to printers and battery and ninety 90 days on non disposable accessories and certain components consisting of reusable SpOz sensors reusable temperature probes and other accessories provided by CAS as part of the original purchase CAS warrants blood pressure cuffs a
10. trace amounts of residue and or fumes NOTE Thoroughly wipe off any excess cleaning solutions Care should be taken to prevent water or cleaning solution to run into connector openings or crevices CAS 740 Monitors THE DISPLAY CAUTION Use care when cleaning the display Scratches may occur Occasionally as needed clean the display window using a soft lint free cloth sprayed with an alcohol free glass cleaner DO NOT use either isopropyl alcohol or solvent to clean the display Use of these cleaners can cause damage to the display The use of paper towels is not recommended as it may scratch the surface CUFFS AND SENSORS Prior to each patient use inspect the blood pressure cuffs SpO2 finger sensor and cables for damage The blood pressure cuffs and finger sensors should periodically be cleaned following the manufacturers instructions for the particular item in use CAUTION Do not sterilize the sensors by steam or any other method or solution Do not immerse the sensors in water or cleaning solution NOTE Refer to the documentation enclosed with each accessory for any additional sterilization or disinfection instructions PNEUMATIC TUBING Prior to each patient use inspect the NIBP Inflation Hose for proper connection cracks and kinks As necessary clean the pneumatic tubing using a soft cloth dampened with a germicidal solution PRINTER When the printer becomes dirty wipe with a soft dry cloth For extreme dirt buildu
11. umstances perform any testing or maintenance on the monitor while the monitor is being used to monitor a patient CAUTION Unplug the monitor from the AC power source and remove all the accessories from the monitor before cleaning The monitor must be turned off and not running on the internal battery Never clean the monitor when it is being operated THE MONITOR On a daily basis examine the monitor s case for any damages and check the AC power cord for bent or broken prongs cracks or fraying Neither the monitor nor the power cord should be used if damaged If any damage is noted contact the appropriate service personnel CAUTION Do not spray any water or cleaning solution directly onto the monitor Every three 3 months or as needed clean the monitor using a soft cloth dampened with a mild dishwashing detergent solution and gently rub the soiled area until clean Use a clean soft cloth to dry the monitor DO NOT use abrasive cleaners on the monitor DO NOT use either isopropyl alcohol or solvent to clean the monitor Use of these cleaners can cause damage to the monitors surface DO NOT immerse the monitor or power cord in the cleaning solution When necessary the monitor surfaces may be disinfected using a soft cloth saturated with a 10 1 10 solution of chlorine bleach in tap water When all of the surfaces have been disinfected wipe the entire surface of the monitor using a soft cloth dampened with fresh water to remove any
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